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The goal of this clinical trial is to evaluate the safety and preliminary efficacy of a 1-year course of IVMED-85 eye drops for the treatment of pediatric myopia by assessing its safety effects on visual acuity and its effect on the change and/or progression of myopia.
The main question[s] it aims to answer are:
Participants will use eyedrops twice a day for one year. Researchers will compare IVMED 85 to a placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IVMED-85 Low Dose and placebo | Experimental | Total subjects n=6 n=4 IVMED 85 Low Dose n=2 placebo BID for 1 month |
|
| IVMED-85 Mid Dose and placebo | Experimental | Total subjects n=6 n=4 IVMED 85 Mid Dose n=2 placebo BID for 1 month |
|
| IVMED-85 High Dose and placebo | Experimental | Total subjects n=6 n=4 IVMED 85 High Dose n=2 placebo BID for 1 month |
|
| IVMED-85 Low Dose | Experimental | Total subjects n=48 IVMED 85 Low Dose BID for 12 month |
|
| IVMED-85 Mid Dose | Experimental | Total subjects n=48 IVMED 85 Mid Dose BID for 12 month |
|
| IVMED-85 High Dose | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IVMED 85 | Drug | Eye drop |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1 Safety - Change in Best corrected distance visual acuity | Best corrected distance visual acuity in the Study Eye | Baseline compared to Day 0, Weeks 1, 2 and 4 (+ 5 days) |
| Phase 1 Safety - Change in Development of corneal scarring | Development of corneal scarring in the study eye | Baseline compared to Day 0, Weeks 1, 2 and 4 (+ 5 days) |
| Phase 1 Safety - Change in Patient assessment of comfort | Patient assessment of burning, redness, discomfort, irritation in the study eye | Baseline compared to Day 0, Weeks 1,2 and 4 (+ 5 days) |
| Phase 1 Safety - Change in Tyroid enzyme levels | Thyroid enzyme levels | Baseline compared to week 4 |
| Phase 1 Safety - Change in Copper serum levels | Copper serum levels | Baseline compared to week 4 |
| Phase 2 Safety - Change in Best corrected distance visual acuity | Best corrected distance visual acuity in the Study Eye | Weeks 1 and 4 (+ 5 days) and Months 3, 6, 9, and 12 (+ 21 days) |
| Phase 2 Efficacy - Change/Progression of myopic refractive error | Change/Progression of myopic refractive error (spherical equivalent as determined by cycloplegic refraction) in the Study Eye | Baseline compared to month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 2 Safety - Change in Development of corneal scarring | Development of corneal scarring in the study eye | Weeks 1 and 4 (+ 5 days) and Months 3, 6, 9, and 12 (+ 21 days) |
| Phase 2 Safety - Change in Patient assessment of comfort |
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Inclusion Criteria:
To be considered for enrollment in the study, the patient must meet all of the following criteria:
Age 5 to 16 years and 6 months, three age groups cohorts (5-8), (9-12), and (13-16) (Phase 1 patients will be exclusively age 13-16).
Refractive error by cycloplegic refraction in both eyes: myopia -0.75 D to -9.75 D spherical equivalent; astigmatism ≤ 4.00D; anisometropia <3.00 D
Best corrected distance visual acuity better than or equal to Snellen 20/40 (logMAR equivalent 0.3) in both eyes
Kmax >40 D and <50 D in both eyes
Minimum corneal thickness > 350 microns in both eyes
Absence of ocular comorbidities (glaucoma, cataract, anterior segment dysgenesis, corneal scarring, juvenile rheumatoid arthritis, lens subluxation, uveitis, collagen disorders (Ehlers-Danlos, Marfan's syndrome, osteogenesis imperfecta, retinal diseases) in both eyes
Written informed consent from a parent or legal guardian and assent from participant
Willing and able to comply with clinic visits and study-related procedures.
Exclusion Criteria:
A patient who meets any of the following criteria, in either eye, will be excluded from the study:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sarah Molokhia, RPH, PhD | Contact | 3852294491 | sarahmolokhia@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Sarah Molokhia | iVeena Delivery Systems, Inc. | Principal Investigator |
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| ID | Term |
|---|---|
| D047728 | Myopia, Degenerative |
| ID | Term |
|---|---|
| D009216 | Myopia |
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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Total subjects n=48 IVMED 85 High Dose BID for 12 month
|
| Placebo | Placebo Comparator | Total subjects n=54 Placebo BID for 12 month |
|
| Placebo | Drug | Placebo eye drop |
|
Patient assessment of burning, redness, discomfort, irritation in the study eye
| Weeks 1 and 4 (+ 5 days) and Months 3, 6, 9, and 12 (+ 21 days) |
| Phase 2 Efficacy - Change in keratometry | Measure keratometry in the Study Eye | Baseline compared to Weeks 1 and 4 (+ 5 days) and Months 3, 6, 9, 12 (+21 days) |
| Phase 2 Efficacy - Change in Axial length | Axial Length in the Study Eye | Baseline compared to Weeks 1 and 4 (+ 5 days) and Months 3, 6, 9, 12 (+21 days) |
| Phase 2 Efficacy - Change in Vitreous chamber depth | Vitreous chamber depth in the Study Eye | Baseline compared to Weeks 1 and 4 (+ 5 days) and Months 3, 6, 9, 12 (+21 days) |
| Phase 2 Efficacy - Intermediate change/progression of myopic refractive error | Change/Progression of myopic refractive error (spherical equivalent as determined by cycloplegic refraction) in the Study Eye | Baseline compared to Weeks 1 and 4 (+ 5 days) and Months 3, 6, 9 (+21 days) |